How to manage Prototyping and Manufacturing of Medical Devices?

How to manage Prototyping and Manufacturing of Medical Devices?

How to manage Prototyping and Manufacturing of Medical Devices?

Managing a team

  • What does a manager do?

A manager is someone who is responsible for a certain group of tasks. Usually, the manager has a set of people working under him or her providing him/her with feedbacks and reports. Most big companies have multiple managers, with each manager being in charge of specific tasks and reporting back to the boss.

what is a manager

In order for someone to become a manager, one must first meet certain criteria such as:

  • Leadership: a manager must be good at setting up goals and motivating the team members to perform better and believe in the company.
  • Communication: a manager must be great at communicating with others whether that be speaking with a large group or one on one conversations.
  • Finance: since the manager is going to control the expenses and the budget, he must be decent in finance and understands how the economy of the company works.
  • Project Management: possibly the most important trait a manager must have is the knowledge of managing a project, distributing of responsibilities and setting up of priorities.
  • Experienced in the field of work: in order to become a good manager, one must first have experience in a certain task in order to understand and know what is the best way in order to perform the best process and task.


  • What are a manager’s duty and obligations?

manager's duties

The duties and responsibilities of a manager differ from a company to another; however, here are some general tasks that a manager should do.

  • Hiring employees and staff.
  • Training new employees if the company offers training programs.
  • Coaching and guiding the employees after training them.
  • Receiving reports and feedbacks and using valuable information in order to properly deal with its performance.
  • Supporting the patrons and bosses in making important decisions and resolutions.
  • Monitoring the performance of the employees and controlling the expenses and the budget.
  • Making plans and setting up goals for a certain period of type.

How to manage Prototyping and Manufacturing of Medical Devices?

  • How to manage the Prototyping process of the Medical Devices

Prototyping of Medical Devices

Prototyping of Medical Devices

In order to create a physical prototype of a medical device or any other product for that matter, one must first create a digital version of the device using a CAD Software such as Solid Edge or PTC Creo. So what are the best tips and great steps in order to develop the best CAD Prototype design of a medical device?

  • The very first step into making a great design is to have an experienced team in designing. Therefore, one must choose the right team members for the right job. The Prototype team must be a combination of designers and engineers. The designers will create the best design and the engineers will determine if the Design is actually possible to manufacture and functional or it is just a design.
  • The next step is to manage the requirements, whether that be the financial requirements, the equipment such as computers, the CAD Software, the 3D printing machine as well as the overall result of the medical device such as the functionality and dimensions…
  • The third step is the quality management, this is probably the most important step in creating anything for that matter; this step includes the documentation of the process as well as having a great workflow and a strategy that the team members will follow strictly. This will ensure the great quality of the end result.
  • The fourth step is to simulate and perform tests on the CAD Model and make necessary changes if required. All while creating reports of the simulation and gathering data and taking notes.

After the validation of the 3D Model, it is the time to create the physical Prototype using various tools and machines such as a 3d printer. So what is the best way to develop the prototype?

  • The first step is to gather the data and notes from the previous steps and using such information one must manage the materials required in order to create the prototype.
  • The second step is to create the physical prototype using a 3D printer and the CAD file.
  • The third step is to perform Tests and validate the efficiency of the prototype. If an iteration process is required, then it should be done also.


Manufacturing of Medical Devices

Manufacturing of a medical device

Now that the physical prototype is validated, it is time to start manufacturing the actual medical device. There are few tips that will guarantee the best quality of the manufacturing of the final product.

  • The first step is to gather the important data and information from the previous steps in order to plan for the next step.
  • The next step is to contact the suppliers all while having the necessary documents and reports.
  • The third step is to start manufacturing the medical device using quality management techniques in order to avoid unnecessary mistakes and wasting of raw materials and ensuring the great quality of the end result.
  • The fourth step is to not rush the manufacturing process and have at least an expert to guide and manage the manufacturing processes and steps to make sure that the workers are following the proper workflow.
  • The fifth step is to document and report on every step and process and send feedbacks to the rest of the team so that the designers, the engineers, and the managers are all kept updated.


In conclusion, the manufacturing of medical products is an extremely challenging field and domain, due to the requirements it demands not to mention the FDA Regulations and laws. However, thanks to the advancement of technology the medical field is getting more available to the mass more than ever.

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